Amarin Corp PLC/UK – ‘6-K’ for 8/24/04

On:  Tuesday, 8/24/04, at 1:16pm ET   ·   For:  8/24/04   ·   Accession #:  1159554-4-25   ·   File #:  0-21392

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Report of a Foreign Private Issuer   —   Form 6-K
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 6-K         Report of a Foreign Private Issuer                     4±    17K 


UNITED STATES     
SECURITIES AND EXCHANGE COMMISSION    
Washington, D.C. 20549    

FORM 6-K    

REPORT OF FOREIGN PRIVATE ISSUER    
PURSUANT TO RULE 13a-16 OR 15d-16   
OF THE SECURITIES EXCHANGE ACT OF 1934  

August 24, 2004 

Commission File Number 0-21392

AMARIN CORPORATION PLC  
(Translation of registrant's name into English)   

7 Curzon Street     
London W1J 5HG      
England       
(Address of principal executive offices)  

Indicate by check mark whether the registrant files or                
will file annual reports under cover of Form 20-F or Form 40-F:                 

Form 20-F [X]       Form 40-F [  ]                

Indicate by check mark whether by furnishing the information          
contained in this Form, the registrant is also thereby furnishing the           
information to the Commission pursuant to Rule 12g3-2(b) under the              
Securities Exchange Act of 1934.                                                

Yes [  ]            No [X]                        

Attachment:                                                                     

Material Events                                                                 

(a) Amarin Corporation announces results of gene variant data analysis          
from initial Miraxion(TM) Phase III clinical trial                      

This report on Form 6-K is hereby incorporated by reference in (a)    
the registration statement on Form F-3 (Registration No. 333-104748) of         
Amarin Corporation plc and in the prospectus contained therein, (b) the         
registration statement on Form F-3 (Registration No. 333-13200) of              
Amarin Corporation plc and in the prospectus contained therein and              
(c) the registration statement on Form F-3 (Registration No. 333-12642)         
of Amarin Corporation plc and in the prospectus contained therein, and          
this report on Form 6-K shall be deemed a part of each such registration        
statement from the date on which this report is filed, to the extent not        
superseded by documents or reports subsequently filed or furnished by           
Amarin Corporation plc under the Securities Act of 1933 or the Securities       
Exchange Act of 1934.                                                           

SIGNATURES          

Pursuant to the requirements of the Securities Exchange Act of 1934,  
the registrant has duly caused this report to be signed on its behalf by        
the undersigned, thereunto duly authorized.                                     

              AMARIN CORPORATION PLC

          By: /s/ Alan Cooke
        Name: Alan Cooke
                      Title: Chief Financial Officer

Date: August 24, 2004                                                           

Index to Exhibits                                                               

Exhibit Item                      Sequentially Numbered Page                    

(a) Material event description                4                                 

Contact:                                                                        
Rick Stewart                                                                    
Chief Executive Officer                                                         
Amarin Corporation plc                                                          
Phone: +44 (0) 207 907 2442                                                     
investor.relations@amarincorp.com                                               

Alan Cooke                                                                      
Chief Financial Officer                                                         
Amarin Corporation plc                                                          
Phone: +44 (0) 207 907 2442                                                     
investor.relations@amarincorp.com                                               

AMARIN CORPORATION ANNOUNCES RESULTS OF GENE        
VARIANT DATA ANALYSIS FROM INITIAL MIRAXION(TM)     
PHASE III CLINICAL TRIAL          

Analysis identifies characteristics of Huntington's disease patients            
responsive to Miraxion(TM)                                                      

LONDON, United Kingdom, August 24, 2004 - Amarin Corporation plc                
(NASDAQSC: AMRN) today announced the results of a gene variant data             
analysis from the initial Phase III clinical trial for Miraxion(TM)             
(formerly referred to as LAX-101) in Huntington's disease.  The                 
analysis identifies a group of patients with a specific gene variant            
that experienced a significant response to Miraxion(TM).  The initial           
twelve month, phase III multi-center, double blind, randomized placebo          
controlled study of Miraxion(TM) was conducted in 2002 by Laxdale               
Limited ("Laxdale") with 135 enrolled patients with Huntington's disease        
at six centers in the United States, Canada, the United Kingdom and             
Australia.  The primary endpoint in the initial trial was the change            
over a one-year period in the Total Motor Score-4 (TMS-4) subscale of           
the Unified Huntington's Disease Rating Scale (UHDRS), the standard             
rating scale for trials in this disease.                                        

The additional data analysis identifies a group of participants in the          
initial study for whom Miraxion(TM) showed a significant clinical               
benefit.  Huntington's disease is believed to be caused by a genetic            
mutation of the cytosine, adenosine and guanine (CAG) polymorphic               
trinucleotide repeat. It is believed that there is a direct link between        
CAG repeat length and age of onset, disease progression and clinical            
symptoms of Huntington's disease.  CAG repeat length can be measured            
via a genetic blood test.                                                       

Efficacy of Miraxion(TM)                                                        

The possibility that treatment efficacy of Miraxion(TM) could be related to     
the number of CAG repeats was proposed as part of the pre-specified analysis    
and exploratory analysis was conducted after completion of the trial to         
examine this influence. A strong correlation between the CAG repeat number      
and the change in TMS-4 score was revealed in those patients taking             
Miraxion(TM).  In order to explore this effect further, patients were split     
into two groups based around the median number of CAG repeats, which was        
identified as 45.  Those patients that took Miraxion(TM) and had a CAG          
repeat length of less than 45 comprised the responsive group.  This effect      
was consistent across all centers.  In total, 67 of the 135 patients in the     
initial phase III study had this specific gene variant.  It is estimated        
that patients with a CAG repeat length of less than 45 represent over 65%       
of all Huntington's disease patients.                                           

The group of patients with a CAG repeat length of less than 45 in the intent    
to treat group receiving Miraxion(TM) showed a statistically significant        
improvement over those patients receiving placebo (p=0.029, n=67). In the       
group of patients with a CAG repeat length of less than 45 who observed the     
clinical trial protocol (per protocol patients) receiving Miraxion(TM)          
showed a 22.7% improvement in TMS-4 score versus patients receiving placebo     
who showed a 5.7% deterioration at the end of the twelve month study            
(p=0.006, n=44).   This improvement was observed over a 6-month period and      
maintained for a further 6 months.  In the 12-month open label continuation     
phase of the trial, this improvement continued to be maintained.  At the end    
of the open-label phase all patients who had taken part in the trial were       
offered compassionate supply.  More than 3 years after the commencement of      
this trial, 101 of the 135 patients enrolled in the trial continue to be        
supplied Miraxion(TM).                                                          

Rick Stewart, Chief Executive Officer of Amarin commented, "This data           
analysis, showing significant clinical benefit to specific patients taking      
Miraxion(TM), will be an important component in the design of the planned       
phase III clinical trials.  It will allow us to more accurately target          
patients with this specific gene variant, particularly relating to age of       
onset of the disease. Improvement and stability are particularly beneficial     
if initiated at an early stage in this devastating disease.  This could         
significantly extend a patient's professional activities, maintain a good       
quality of life, and potentially defer the onset of the later stages of the     
disease."                                                                       

Planned Phase III Trials                                                        

Amarin intends to commence two phase III clinical trials totaling over 400      
Huntington's disease patients in early 2005, subject to consummation of         
Amarin's proposed acquisition of Laxdale and the completion of an equity        
fund raising.                                                                   

Miraxion(TM) has been granted Fast Track designation for Huntington's disease   
by the United States Food and Drug Administration and received Orphan Drug      
designation both in the U.S. and in Europe.  Miraxion(TM) is also in clinical   
development for depression.                                                     

Huntington's Disease                                                            

Huntington's disease is a genetic neurodegenerative disease characterized       
by movement disorder, dementia and psychiatric disturbance.  It has been        
diagnosed in approximately 30,000 patients in the U.S. with a similar number    
in Europe.  Additionally, over 200,000 persons in the U.S. alone are            
genetically "at risk" to developing the disease.  Onset of symptoms is          
typically between 30-50 years of age with a typical life expectancy from        
diagnosis of 10-25 years. Patients with late stage disease require continuous   
nursing care, often in nursing homes, with an estimated annual cost to the      
U.S. economy of up to $2.5 billion.  Presently, there is no effective           
treatment or cure for HD.                                                       

About Amarin Corporation                                                        

Amarin Corporation is a neuroscience company focused on the development and     
commercialisation of novel drugs for the treatment of neurological disorders    
affecting the central nervous system.                                           

For press releases and other corporate information, visit our website at        
http://www.amarincorp.com.                                                      

Statements in this press release that are not historical facts are forward-     
looking statements that involve risks and uncertainties which may cause the     
Company's actual results in future periods to be materially different from      
any performance suggested herein.  Such risks and uncertainties include,        
without limitation, the uncertainty of entering into and consummating a         
definitive agreement on terms acceptable to the parties, the inherent           
uncertainty of pharmaceutical research, product development and                 
commercialization, the impact of competitive products and patents, as well as   
other risks and uncertainties detailed from time to time in periodic reports.   
For more information, please refer to Amarin Corporation's Annual Report for    
2003 on Form 20-F and its Form 6-Ks as filed with the U.S. Securities and       
Exchange Commission.  The company assumes no obligation to update information   
on its expectations.                                                            

Dates Referenced Herein   and   Documents Incorporated by Reference

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